We are seeking a proactive and detail-oriented Maintenance Engineer to support the development and implementation of maintenance strategies for a new state-of-the-art medical device manufacturing facility currently under construction. This role is ideal for someone who thrives in a collaborative, cross-functional environment and has a strong foundation in technical writing, engineering documentation, and data gathering from diverse project stakeholders.
Key Responsibilities
Qualifications & Experience
Note: Hybrid work options available following initial onboarding and training. Competitive salary and benefits package including healthcare and pension.
Key Responsibilities
- Collaborate closely with engineering, commissioning, and operations teams to support the phased introduction of utility and process systems in alignment with project milestones.
- Lead the development of maintenance job plans and technical documentation (SOPs, SWIs) for new equipment and systems using the site’s CMMS (Maximo).
- Gather and consolidate technical data from engineering drawings, vendor documentation, and commissioning records to inform maintenance package development.
- Participate in cross-functional reviews of Commissioning & Qualification (C&Q) outputs to ensure maintenance requirements are captured and aligned with global standards.
- Support the implementation of the CMMS by preparing and validating data load templates for maintenance and calibration activities.
- Conduct spare parts analysis and define stocking strategies in collaboration with procurement and engineering teams.
- Contribute to Failure Mode Effects and Criticality Analysis (FMECA) and Reliability-Cantered Maintenance (RCM) workshops to define optimal maintenance strategies.
- Ensure all documentation complies with Good Documentation Practices (GDocP) and Good Manufacturing Practices (GMP).
- Assist in tracking progress against the Asset Management Development schedule and escalate issues as needed.
- Leverage existing documentation and maintenance strategies from other facilities to streamline development efforts.
- Participate in site walkdowns and equipment reviews to validate maintenance readiness and support technician training.
Qualifications & Experience
- Degree in a relevant engineering discipline.
- Minimum 3 years of hands-on experience in maintenance engineering role, ideally in the biopharma or medical device sector.
- Proven experience in developing maintenance job plans and identifying spare parts requirements.
- Strong understanding of GMP and maintenance best practices in regulated environments.
- Ability to interpret P&IDs, utility schematics, and HVAC drawings.
- Proficiency in Microsoft Office, CMMS Systems, Document Management Systems; experience with Maximo is a plus.
- Excellent communication and collaboration skills, with a strong focus on documentation and process alignment.
Note: Hybrid work options available following initial onboarding and training. Competitive salary and benefits package including healthcare and pension.
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